DiabetesPRESENTNCT01536600
Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in South Korea.
Trial summary
This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart 30
- How many people
- 33,010 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2004to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)
Who may be able to join
- Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice
This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biphasic insulin aspart 30Drug
The insulin dose and regimen was individualised at the physician's discretion
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 30 users | Not described Receives: Drug: biphasic insulin aspart 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (glycosylated haemoglobin)
Secondary outcomes (5)
Change in post prandial glucose (PPG)
Change in fasting glucose (FG)
Difference in prandial glucose increment (PGI)
Incidence of hypoglycaemic episodes
Adverse drug reactions (ADR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startSep 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536600
- Sponsor's protocol ID
- BIASP-1880
- Acronym
- PRESENT
- Status last verified
- Jan 2017
- First submitted
- 16 Feb 2012
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Guler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, Shestakova M, Khutsoane D, Bech OM. Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results. Arch Drug Inf. 2009 Jun;2(2):23-33. doi: 10.1111/j.1753-5174.2008.00015.x.
PubMed 19684847Khutsoane D, Sharma SK, Almustafa M, Jang HC, Azar ST, Danciulescu R, Shestakova M, Ayad NM, Guler S, Bech OM; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab. 2008 Mar;10(3):212-22. doi: 10.1111/j.1463-1326.2007.00826.x.
PubMed 18269636Shestakova M, Sharma SK, Almustafa M, Min KW, Ayad N, Azar ST, Danciulescu R, Khutsoane D, Guler S. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007 Dec;23(12):3209-14. doi: 10.1185/030079907X253636.
PubMed 18005503Gao Y, Guo XH, Vaz JA; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab. 2009 Jan;11(1):33-40. doi: 10.1111/j.1463-1326.2008.00904.x. Epub 2008 May 20.
PubMed 18494806Jang HC, Guler S, Shestakova M; PRESENT Study Group. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract. 2008 Jul;62(7):1013-8. doi: 10.1111/j.1742-1241.2008.01792.x. Epub 2008 May 9.
PubMed 18479365
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01536600
- Acronym / sponsor ID
- PRESENT / BIASP-1880
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33,010 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIAsp 30 users | – | Drug: biphasic insulin aspart 30 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)
Key inclusion criteria (1 listed)
- Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biphasic insulin aspart 30The insulin dose and regimen was individualised at the physician's discretion | Drug | BIAsp 30 users |
Primary outcome
Change in HbA1c (glycosylated haemoglobin)
5 secondary outcomes
Change in post prandial glucose (PPG)
Change in fasting glucose (FG)
Difference in prandial glucose increment (PGI)
Incidence of hypoglycaemic episodes
Adverse drug reactions (ADR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Results publication: PubMed 19684847Guler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, Shestakova M, Khutsoane D, Bech OM. Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results. Arch Drug Inf. 2009 Jun;2(2):23-33. doi: 10.1111/j.1753-5174.2008.00015.x.
- Results publication: PubMed 18269636Khutsoane D, Sharma SK, Almustafa M, Jang HC, Azar ST, Danciulescu R, Shestakova M, Ayad NM, Guler S, Bech OM; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab. 2008 Mar;10(3):212-22. doi: 10.1111/j.1463-1326.2007.00826.x.
- Results publication: PubMed 18005503Shestakova M, Sharma SK, Almustafa M, Min KW, Ayad N, Azar ST, Danciulescu R, Khutsoane D, Guler S. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007 Dec;23(12):3209-14. doi: 10.1185/030079907X253636.
- Results publication: PubMed 18494806Gao Y, Guo XH, Vaz JA; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab. 2009 Jan;11(1):33-40. doi: 10.1111/j.1463-1326.2008.00904.x. Epub 2008 May 20.
- Results publication: PubMed 18479365Jang HC, Guler S, Shestakova M; PRESENT Study Group. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract. 2008 Jul;62(7):1013-8. doi: 10.1111/j.1742-1241.2008.01792.x. Epub 2008 May 9.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (glycosylated haemoglobin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01536600, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.